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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-002245-66
    Sponsor's Protocol Code Number:PDTZ02
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2015-002245-66
    A.3Full title of the trial
    Impact of light dose on the efficacy of Photodynamic therapy with 5-aminolaevulinic acid (5-ALA) and a 635 +- 9nm emitting LED-lamp for the treatment of actinic keratoses - a randomized, observer-blinded, intraindividual trial
    Einfluss der Lichtdosis auf das Ansprechen von aktinischen Keratosen 12 Wochen nach Photodynamischer Therapie mit 5-Aminolävulinsäure (5-ALA) und einer 635+- 9 nm emittierenden LED-Lichtquelle - eine randomisierte, Untersucher-geblindete, intraindividuelle Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ALA-PDT with different light doses in patients with actinic keratoses
    ALA-PDT mit unterschiedlichen Lichtdosen bei Patienten mit aktinischen Keratosen
    A.3.2Name or abbreviated title of the trial where available
    Different light doses ALA-PDT AKs
    Verschiedene Lichtdosen ALA-PDT AKs
    A.4.1Sponsor's protocol code numberPDTZ02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedizinische Universität Wien, Univ. Klinik f. Dermatologie
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedizinische Universität Wien, Univ. Klinik für Dermatologie
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Univ. Klinik für Dermatologie
    B.5.2Functional name of contact pointUniv. Klinik für Dermatologie
    B.5.3 Address:
    B.5.3.1Street AddressWaeringer Guertel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.4Telephone number+4314040077020
    B.5.5Fax number+4314040076990
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Ameluz
    D. of the Marketing Authorisation holderBiofontera Bioscience GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAmeluz
    D.3.2Product code EMEA/H/C/002204-N/005
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-aminolevulinic acid hydrochloride
    D.3.9.1CAS number 106-60-5
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID
    D.3.9.4EV Substance CodeSUB12853MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number78
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic keratoses (AK) as precursors of squamous cell carcinoma (SCC) of the skin
    Aktinische Keratosen (AK) als Vorstufen des Plattenepithelkarzinoms an der Haut
    E.1.1.1Medical condition in easily understood language
    Early, superficial skin cancer
    Früher, oberflächlicher Hautkrebs
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Clearance of actinic keratoses 12 weeks after last Photodynamic treatment (PDT) with different light doses and/or fluence rates
    Abheilungsrate von aktinischen Keratosen 12 Wochen nach der letzten Photodynamischen Therapie (PDT) mit verschiedenen Lichtdosen und/oder Lichtintensitäten
    E.2.2Secondary objectives of the trial
    Tolerability (pain), relapse rate, cosmetic outcome, local phototoxic reaction, global patient satisfaction
    Schmerzintensität, Rezidivrate, lokale phototoxische Reaktion, kosmetisches Ergebnis und globale Patientenzufriedenheit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >18 years and ≤ 90 years
    Patients with at least 4-8 actinic keratosis in the face and/or scalp
    Olsen stage I-II
    Distance between lesions should be about 1 cm
    Size of lesions >0,5 and <2,5 cm
    Skin type I-IV
    Alter > 18 Jahre und ≤ 90 Jahre
    4-8 klinisch oder bioptisch verifizierte aktinische Keratosen, die symmetrisch über 4 Quadranten (à 5x5 cm) der unbehaarten Kopfhaut oder des Gesichtes verteilt sind
    Olsen Grad I-II
    Abstand zwischen einzelnen AKs ca. 1 cm
    Größe der einzelnen AKs > 0,5 cm und < 2,5 cm
    Hauttyp I-IV nach Fitzpatrick
    E.4Principal exclusion criteria
    Actinic keratoses with Olsen stage> II
    Photodermatoses like Porphyria cutanea tarda, PLE or Xeroderma pigmentosum
    Diseases that will be aggravated by light, e.g. lupus erythematodes
    Porphyria or intake of photosensitizing drugs
    Known allergy to aminlevulinic acid
    specific treatment during the last 4 weeks
    Patients with severe compromised general state
    Participation in another clinical trial
    Patients unable to stick to the study protocol
    Patients not able to give written informed consent
    Pregnant or lactating women
    skin type V-VI
    allergy against peanuts or soya

    Aktinische Keratosen mit Olsen Grad> II
    Photodermatosen unterschiedlicher Ätiologie, z.B. Stoffwechselstörungen wie Aminoazidurie, polymorphe Lichtdermatose, genetische Störungen wie Xeroderma pigmentosum
    Erkrankungen, die durch Exposition gegenüber Sonnenlicht ausgelöst oder verschlimmert werden wie verschiedene Formen des Lupus erythematodes
    Porphyrie oder die Einnahme von photosensibilisierenden Medikamenten wie z.B. Johanniskraut, Griseofulvin, Thiaziddiuretika, Sulfonylharnstoffe, Phenothiazine, Sulfonamide, Chinolone und Tetrazykline
    Unverträglichkeit gegenüber Aminolävulinsäure
    Spezifische lokale Vortherapien des Hauttumors innerhalb der letzten 4 Wochen
    Schwere Beeinträchtigung des Allgemeinzustandes
    Teilnahme an einer anderen dermatologischen Studie
    Unvermögen, den Behandlungsplan zu befolgen bzw. den Pflichten des Studienteilnehmers nachzukommen
    Patienten, die ihr schriftliches Einverständnis nicht erteilen können, z.B. aufgrund geistiger Behinderung oder Sachwalterschaft
    Schwangere und stillende Frauen
    Hauttyp V-VI nach Fitzpatrick
    Allergie gegen Erdnüsse oder Soja

    E.5 End points
    E.5.1Primary end point(s)
    Complete clearance of actinic keratosis 12 weeks after completion of treatment
    Komplette Abheilung der aktinischen Keratosen 12 Wochen nach Ende der Therapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last PDT
    12 Wochen nach letzter PDT
    E.5.2Secondary end point(s)
    Tolerability (pain), relapse rate, cosmetic outcome, local phototoxic reaction, global patient satisfaction
    Schmerzintensität, Rezidivrate, lokale phototoxische Reaktion, kosmetisches Ergebnis und globale Patientenzufriedenheit
    E.5.2.1Timepoint(s) of evaluation of this end point
    - pain: during treatment, at the end of treatment, 10 minutes, 2 days and 7 days after treatment
    - relapse rate: 24 weeks after last PDT
    - local photoxic reaction: immediate assessment at the end of the treatment, 10 minutes, 2 days and 7 days after treatment
    - cosmetic outcome: 12 and 24 weeks after last PDT
    - global patient satisfaction: 12 and 24 weeks after last PDT
    - Schmerzen: während, am Ende der Therapie, 10 Minuten, 2 Tage und 7 Tage nach der letzten Behandlung
    - Rezidivrate: 24 Wochen nach letzter PDT
    - lokale phototoxische Reaktion: unmittelbar nach der Behandlung, sowie 10 Minuten, 2 Tage und 7 Tage danach
    - kosmetisches Ergebnis: nach 12 und 24 Wochen
    - globale Patientenzufriedenheit: 12 und 24 Wochen nach letzter PDT
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Untersucher-geblindet, monozentrisch, intraindividuell, prospektiv
    observer-blinded, monocentric, intraindividual, prospective
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Vergleich verschiedener Lichtdosen in ein und demselben Patienten
    comparators are fields treated with different light doses in one individual patient
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state67
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment after completion of the study will be according to current standard of care for this condition
    Die Patienten werden im Routinebetrieb der dermatologischen Ambulanz weiter betreut
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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